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Intrauterine Environment in Polycystic Ovary Syndrome (PCOS) Probands

Genes, Androgens and Intrauterine Environment in PCOS

Polycystic ovary syndrome (PCOS) is among the most common endocrine disorders in premenopausal women, affecting 7-10% of this population. This syndrome is characterized by elevated levels of testosterone and chronic anovulation, and frequently of obesity. This study is designed to test the hypothesis that there is in utero testosterone excess, altered insulin secretion, and/or intrauterine growth retardation in the female offspring of women with PCOS. The allele 8 can be used to identify the reproductive and metabolic abnormalities associated with PCOS. This study will determine whether allele 8 positive [A8(+)] female offspring have more profound changes in these parameters compared to A8(-) female offspring.

Androgen and insulin levels in amniotic fluid from pregnant women with PCOS will be compared to levels in pregnant control women. Androgen and insulin levels in cord blood will also be measured. Further, gestational age and anthropomorphic measurements in offspring of women with PCOS will be assessed and compared to that in offspring of matched control women.

We will test the hypothesis that androgens are elevated in infancy in the female offspring of women with PCOS. We will assess sex steroids, insulin, and c-peptide levels in infants of PCOS women and compare them to the levels in infants of control women up to 1 year of age during the minipuberty of infancy. We will determine whether any of these parameters differ in A8(+) compared to A8(-) PCOS offspring.

Studieöversikt

Status

Avslutad

Detaljerad beskrivning

BACKGROUND Polycystic ovary syndrome (PCOS) is among the most common endocrine disorders in premenopausal women, affecting 7-10% of this population. This syndrome is characterized by hyperandrogenism, chronic anovulation and, frequently, obesity. Hyperandrogenemia seems to be a consistent reproductive phenotype in male relatives as well as female relatives of PCOS women. This phenotype appears to have a genetic basis in PCOS families and shows significant linkage and association with a marker locus on chromosome 19p in the region of the insulin receptor (allele 8 of D19S884.). This allele is also recently found to be associated with a metabolic phenotype in PCOS probands and their brothers, including increased post-challenge glucose levels, apparent defects in insulin secretion, especially in response to sulfonylurea, and accelerated weight gain with age (unpublished date). Therefore, allele 8 status in PCOS probands and their family members can identify the reproductive and metabolic abnormalities.

Many epidemiologic studies showed a plausible link between low birth weight and chronic metabolic disorders manifested as hypertension, diabetes and obesity later in life, suggestive of an early fetal programming. There is evidence to support fetal origin of PCOS. Female rhesus monkeys that were exposed to excess androgen in utero, were born smaller for gestational age. These animals had many of the reproductive features of PCOS, including increased LH levels, irregular ovulation, polycystic ovaries and functional ovarian hyperandrogenism. Similarly, in retrospective cohort studies, girls with elevated adrenal androgen levels or with PCOS were significantly smaller for gestational age at birth than reproductively normal control girls, suggestive of a possible fetal origin for some features of PCOS in human studies. Molecular mechanism for fetal programming is not clearly understood, but permanent changes in gene expression caused early insult may be a factor.

HYPOTHESIS These observations have led to a new hypothesis for the etiology of PCOS; genetic variation resulting in hyperandrogenemia leads to many of the reproductive and metabolic features of PCOS later in life. We will directly test the hypothesis that there is an excess androgen production in female offspring of women with PCOS. Further, we will test whether A8(+) female offspring have more profound changes in these parameters (increased androgen and/or decreased insulin levels in fetal life and in infancy) compared to A8(-) female offspring.

Studietyp

Observationell

Inskrivning (Faktisk)

70

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

    • Illinois
      • Chicago, Illinois, Förenta staterna, 60611
        • Northwestern University School of Medicine

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

  • Barn
  • Vuxen
  • Äldre vuxen

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Kvinna

Testmetod

Icke-sannolikhetsprov

Studera befolkning

Women with PCOS and control women and their offspring

Beskrivning

Probands who meet the following criteria will be enrolled:

Menses < 6 per year without confounding meds Not taking confounding medications at the time of hormone analysis, willing to be off confounding medications for required washout period, or able to provide documentation of hyperandrogenemia (without hyperprolactinemia or evidence of non-classical adrenal hyperplasia) with past laboratory tests during a time when not taking confounding medications Total Testosterone >58 ng/dl or bioavailable testosterone >15 ng/dl Prolactin <25 ng/ml Baseline 17-OHP <3 ng/ml (and stimulated 17-OHP <10 ng/ml if subject is studied on-site)

Control women who meet the following criteria will be enrolled:

History of completely regular menstrual cycles. No history of hirsutism or alopecia. Control women will have a blood sample obtained 3-6 months after they have stopped lactating and resumed regular menses to ensure that they have normal T, uT and DHEAS levels.

Any pregnant woman who develops gestational diabetes will be excluded from the analysis.

To exclude disorders associated with insulin resistance, control subjects will have no personal history of hypertension or hypertriglyceridemia and no first-degree relative with Type 2 DM

Exclusion Criteria:

  • history of gestational diabetes mellitus, eclampsia, pre-eclampsia or any medical disorders complicating their pregnancies.

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Observationsmodeller: Case-Control
  • Tidsperspektiv: Blivande

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Estradiol Level in Female Offspring
Tidsram: One time sampling from the cord blood
The blood that were analyzed were taken from cord blood and not from the offspring.
One time sampling from the cord blood
Androstenedione Level in Female Offspring
Tidsram: cord blood
cord blood
Testosterone Level in Female Offspring
Tidsram: cord blood
cord blood
17-hydroxyprogesterone Level in Female Offspring
Tidsram: cord blood
cord blood
Dihydrotestosterone Level in Female Offspring
Tidsram: cord blood
cord blood
Dehydroepiandrosterone Level in Female Offspring
Tidsram: cord blood
cord blood
Infant Birth Weight (Male and Female)
Tidsram: birth
birth

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Utredare

  • Huvudutredare: Andrea E Dunaif, MD, Chief, Division of Endocrinology, Metabolism and Molecular Medicine

Publikationer och användbara länkar

Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart

1 januari 2003

Primärt slutförande (Faktisk)

1 juli 2012

Avslutad studie (Faktisk)

1 juli 2012

Studieregistreringsdatum

Först inskickad

15 augusti 2006

Först inskickad som uppfyllde QC-kriterierna

15 augusti 2006

Första postat (Uppskatta)

16 augusti 2006

Uppdateringar av studier

Senaste uppdatering publicerad (Uppskatta)

10 april 2013

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

3 april 2013

Senast verifierad

1 april 2013

Mer information

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

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